Bioequivalence and Bioavailability Forum • Replicate Pilot study

Replicate Pilot study [Power / Sample Size]

posted by kumarnaidu – Mumbai, India, 2014-04-11 09:37 (4450 d 11:24 ago) – Posting: # 12807
Views: 16,376

Hello everyone,
In one of my 2x2 crossover pilot study (N = 12) I am getting results as follows
Cmax-62.57(38.27 - 102.29) CV-83.85
AUCt-46.09(17.47 - 121.55) CV-263.48
As per experts study failed drastically because of its design (2x2 cross over), and replicate design should be used here instead of 2x2 design.
In my opinion there may be design issue but the test product is also not upto the mark. Please provide your suggestions. Is there a need of change in design of pilot study or test product modification?

—
Kumar Naidu

Complete thread:

sample size for partial replicate - USFDA niraj.bhatt 2013-10-17 08:53
- sample size for partial replicate - USFDA jag009 2013-10-17 15:09
  - sample size for partial replicate - USFDA niraj.bhatt 2013-10-18 08:18
    - Table A3 Helmut 2013-10-18 13:51
      - N=24 or N=27 d_labes 2013-10-18 14:34
        
        in praise of 100,000 sim’s Helmut 2013-10-18 15:02
        N=24 or N=27 niraj.bhatt 2013-10-19 06:19
      - Table A3 niraj.bhatt 2013-10-19 06:18
- forget the partial replicate Helmut 2013-10-18 00:14
  - forget the partial replicate niraj.bhatt 2013-10-18 07:57
    - PowerTOST and RSABE d_labes 2013-10-18 11:16
  - Replicate Pilot studykumarnaidu 2014-04-11 07:37
    - Replicate Pilot study ElMaestro 2014-04-11 10:27
      - Replicate Pilot study kumarnaidu 2014-04-11 12:45
        
        Replicate Pilot study ElMaestro 2014-04-11 13:23
        
        Replicate Pilot study kumarnaidu 2014-04-14 06:22